a study comparing the effect of dulaglutide with liraglutide in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to assess the benefits and risks of once-weekly dulaglutide compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate glycemic control on metformin.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * not optimally controlled on diet and exercise and a dose of metformin that is at least 1500 milligrams/day (mg/day) and has been at a stable dose for at least 3 months prior to the first study visit * glycosylated hemoglobin (hba1c) greater than or equal to 7.0% and less than or equal to 10.0% * accept continued treatment with metformin throughout the trial, as required per protocol * men and nonpregnant women aged greater than or equal to 18 years * stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening * body mass index (bmi) less than or equal to 45 kilograms/square meter (kg/m\^2) exclusion criteria: * have type 1 diabetes mellitus * have been treated with any other antihyperglycemic medications (other than metformin) at the time of the first study visit or within the 3 months prior to the first study visit * have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any insulin use within 3 months prior to the first study visit * have been treated with drugs that promote weight loss within 3 months of the first study visit * are receiving chronic (greater than 14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit * have had any of the following cardiovascular conditions within 2 months prior to the first study visit: acute myocardial infarction, new york heart association class iii or class iv heart failure, or cerebrovascular accident * have a known clinically significant gastric emptying abnormality (such as, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery * have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase level greater than or equal to 3 times the upper limit of normal * have a history of chronic pancreatitis or acute idiopathic pancreatitis or were diagnosed with any type of acute pancreatitis within the 3 month period prior to the first study visit * have a serum creatinine greater than or equal to 1.5 milligrams/deciliter (mg/dl) (male) or greater than or equal to 1.4 mg/dl (female), or a creatinine clearance less than 60 milliliters/minute (ml/minute) * have any self or family history of type 2a or type 2b multiple endocrine neoplasia (men 2a or 2b, respectively) in the absence of known c-cell hyperplasia (this exclusion includes those participants with a family history of men 2a or 2b whose family history for the syndrome is rearranged during transfection (ret) negative; the only exception for this exclusion will be for participants whose family members with men 2a or 2b have a known ret mutation and the potential participant for the study is negative for that ret mutation) * have any self or family history of medullary c-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of men 2a or 2b syndrome) * have a serum calcitonin greater than or equal to 20 picograms/milliliter (pg/ml)